The Hippocratic Oath, in part, says, “if you can do no good, at least do no harm.” There are thousands of people, men and women, mothers, fathers, wives and husbands, grandparents who have died in the past four years, who would be alive today if they hadn’t taken the anti-arthritic drug Vioxx; make that tens of thousands. Recently, Dr. David Graham, Associate Science Director for the FDA’s Office of Drug Safety, estimated that between 26,000 and 56,000 patients may have died since 1999 when the Food and Drug Administration declared Vioxx safe for public use. In fact, more recent reports suggest that the numbers of the dead may be closer to over 130,000.
Before declaring it safe, FDA researchers knew of serious health problems associated with Vioxx use. Recently released internal documents show Merk chemists knew in 1996 that Vioxx increased heart attacks and strokes. Indeed, a year before Vioxx’s release, a Merk researcher gave the company scientific results showing the problem. The drug reduced the body’s natural release of an anti clotting agent, thus increasing the risk of potentially deadly blood clots. Indeed, the FDA’s own medical officers found a study in 1999 showing that Vioxx use increased the likelihood of strokes or heart attacks, three times more than patients taking a placebo or a pill with no medicine. Yet, with these facts in hand, Merk sought FDA approval to release the drug, and the FDA dutifully granted it.
Indeed, in May 2000 when Merk’s own studies confirmed the much higher heart attack risk, over that of the safer anti arthritic Naproxen, Merk continued to peddle Vioxx. What did the FDA do? It requested Merk add a notice to the warning label. Some 18 months later, they came up with a wording for the label. Vioxx use would continue to cause heart attacks and strokes among thousands, tens of thousands, over 100,000 people, for three years, until Merk pulled the drug. Recently, Dr. Graham told the Senate Finance Committee that the U.S. public is virtually defenseless against deadly medicines. First, “give no deadly drug” was the core of the Hippocratic Oath. Under the present system, it should be changed to “first get paid, let the patient look out for herself.” From death row, this is Mumia Abu-Jamal.
These commentaries are produced by Noel Hanrahan for Prison Radio.
